Low profile heat and moisture exchanger device for tracheotomy and speaking valve

ABSTRACT

A heat moisture exchange device received on a speaking tube mounted on an end of a tracheotomy tube. The heat moisture exchange device has a housing in which the air moves in a turbulent manner and passes through a heat moisture exchange filter.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a broadening reissue of U.S. patentapplication Ser. No. 13/199,525, filed Sep. 1, 2011, now U.S. Pat. No.8,887,718, issued Nov. 18, 2014, which is a continuation-in-part ofpatent application Ser. No. 12/928,648 filed Dec. 16, 2010, nowabandoned the disclosure and contents of which are included by referenceherein in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is directed to a heat moisture exchange devicewhich is usable with a tracheotomy tube and a tracheotomy tube combinedwith a speaking valve.

Tracheotomy is a surgical procedure which is frequently performed torelieve obstruction of airflow through the larynx and upper trachea. Oneof its main side effects is loss of essential breathing functionsincluding humidification, warming and filtering of air, coughing,smelling, tasting, swallowing, and more devastatingly, speaking. Intracheotomy patients, because inhaled air enters the trachea directly,it is very important for health reasons and for the patient's comfort,that the inhaled air is at substantially the same temperature andcontains the same quantities of moisture and dust as if it had reachedthe trachea after passing through the upper airway (nostrils, nose,pharynx and larynx), meaning a temperature approaching 32° Celsius witha moisture content approaching saturation at the temperature of this airand substantially free of dust. HME's (Heat Moisture Exchanger) enablethis result to be achieved to some degree; the filter mass blocks amajor part of the dust in suspension in the air, of course, the watervapor contained in the patient's exhaled air, which is saturated at thetemperature of the organism, condenses on the filter mass which istherefore heated substantially to the body temperature; inhaled air,arriving at the temperature of the ambient air, is warmed and takes upmoisture in contact with the filter mass which is at a highertemperature and contains the condensed water before traveling into thepatient's lungs with inhalation.

In order to overcome these undesirable side effects of a tracheotomyprocedure, the passive HME was developed and has been available for manyyears. An HME consists of a housing to direct exhaled airflow from thepatient, through one of many types of humidifying and moisturizingmedia. This device is placed externally in between the outside air andthe patient's air intake at the tracheotomy tube. Exhaled air from thepatient enters the HME, is directed across the media. The media servesto absorb and retain moisture from the exhaled air. On inspiration,humidified and warmed air is then breathed in by the patient, thusachieving some of the effect of the natural nasal passage. The ebb andflow of air across its surface allows a recurring transference ofmoisture from the patient's exhaled air to the HME and back to thepatient. The HME's hence provide humidification warming and filtrationof air that the tracheotomy patients breathe. The problem with thecurrent HME's on the market is that because air flow inside them islinear, the exchange of humidity and warmth of the air that flowsthrough the HME is not very efficient, hence a relatively large amountof HME foam material is needed, hence making the device quite bulky andunattractive to the patient. The present invention introduces a noveltype of HME having a shape which is compact and designed to redirectairflow inside the HME in a turbulent fashion, hence enhancing theefficiency of humidification, warming and filtration of air.

Another problem is that because HME's moisturize and filter exhaled air,there is no one HME that can work with the speaking valves that arecurrently on the market because the valves are closed upon exhalationand do not allow air to pass. This invention addresses this issue andsolves this problem by introducing an HME that works in combination witha speaking valve to allow both air moisturizing AND speech.

One additional significant situation that tracheotomy patients face isloss of speech. When a tracheotomy is present, exhaled air follows thepath of least resistance, and goes through the tube, limiting thevibratory movement of the vocal cords, and hence limiting perceptualspeech. This creates a psychological hardship, as communication iscritical to patients' overall medical care and social interactions. Thisproblem can be particularly disruptive in children, where tracheotomycan actually impact the development of normal language skills. In orderto redirect the air through the vocal cords, the patient may use afinger to occlude the tracheotomy tube. Finger occlusion however hasseveral limitations: it requires manual dexterity (which some patientsmay lack); it also requires coordination of phonation with breathing(which some patients may be unable to perform); and it is unsanitary.The use of a tracheotomy speaking valve enables tracheotomy patients tospeak without having to occlude the tracheotomy tube with their finger.Unidirectional speaking valves have a displaceable element that allowsair to flow through the cannula and into the lungs during inspirationand prevent air from flowing through the cannula during exhalation.Thus, during expiration, air flows through the patient's upper airways,such as the sub-glottic trachea, larynx, pharynx, mouth and nasalpassages. As a result, unidirectional speaking valves allow tracheotomyindividuals to communicate orally and maintain clear upper airwaypassages by coughing or expelling air through the upper airway passages.

The problem is that there is no one speaking valve currently on themarket that can be used in combination with an HME's, the patient whouse these speaking valves are unable to humidify/warm and filter the airthat they inhale. This is due to the fact that the current speakingvalves on the market are “biased closed”, which means that, while theyallow redirection of air towards the larynx during exhalation (andsubsequent speech), they do NOT allow exhaled air to flow through thevalve. This limitation places the tracheotomy patient in the unfortunateposition of being able to speak with a speaking valve, but not beingable to use an HME in order to humidify/warm and purify the breathedair. The object of this invention is to introduce an HME that canfunction in combination with a speaking valve and humidify/warm andpurify the air that a tracheotomy patient breathes.

In the parent application, we have previously described a speaking valvewith a ball that moves inside a chamber where eccentrically positionedramps act as a stop mechanism and also act as a dynamic guide thatdirects the ball towards the front or the back of the chamber. Thepatient can vary the position of the valve (valve “up” or valve “down”)by rotating it 180° up or down, and this allows the ball to be seated inthe proximal part of the chamber either in the “biased open” or biasedclosed” position. This feature gives the patient control on the use ofthe valve to preferentially allow the exhaled air to escape through theproximal opening or redirect the air towards the larynx and speak.

The current invention is a continuation in part of the previousinvention, extending the functionality of our previously describeddynamic speaking (valve “up” or valve “down”) (which allows “biasedopen” or “biased closed” usage) to be able to combine it with an HME forthe sake of speech AND humidification, warming, and filtration of air.

2. Description of Related Art

A variety of one-way speaking valves has been described in theliterature and is on the market. These include the Passy-Muir valve, theShiley Phonate valve, the Kistner valve and the Montgomery speakingvalve, and they operate via a flap or diaphragm. These “flapper” valvesclose on exhalation in order to provide speech; hence they cannot beused in combination with an HME. Prior U.S. Pat. No. 5,505,198 (Siebenset al) describes a unidirectional tracheotomy speaking valve with anexternal cylindrical housing chamber that contains a ball acting as thedisplaceable element. The ball moves back and forth during inspirationand expiration, and is limited from going beyond the housing chamberduring inspiration by a pin or a wire that extends into the chamber andintersects a path of travel of the ball, preventing it from entering thepatient's airway. In this patent, the housing chamber is external to thetracheotomy tube and attached to the cannula of a tracheotomy tubethrough coupling. U.S. Pat. No. 6,588,428 (Shikani et al) describes asimilar design unidirectional speaking valve in which the housingchamber is internal and an integral part of the inner cannula of thetracheotomy tube, the ball is guided by longitudinal ribs and isrestrained in the cannula by a wire.

While these ball valve patents constitute a substantial improvement inthe art over the flapper valves, nevertheless, the fact that the valvehousing chamber is a simple cylindrical tube that houses a ball thattravels back and forth along the tube's central axis, with no guidingribs that could potentially direct the movement of the ball depending onthe orientation of the valve (valve “up” or “down”). This unidirectionalball speaking valve cannot be used in concert with an HME.

BRIEF SUMMARY OF THE INVENTION

The present invention provides an improved heat moisture exchange devicefor use with a tracheotomy tube and with a tracheotomy tube in concertwith a speaking valve.

Eccentrically positioned ramps inside the chamber of the ball speakingvalve act as a stop mechanism but also act as a dynamic guide thatdirects the ball towards the front or the back of the chamber, dependingon the position of the valve (valve “up” or valve “down”). The eccentricramps allow a method of using the speaking valve in two differentpositions, and providing a positive ball positioning feature dependinghow the housing chamber is rotated, hence greatly improving performance.In one mode, with the valve oriented “down”, the ball is automaticallyheld fully seated towards the front opening of the valve body, when thepatient is breathing regularly at rest. This innovation allows the ballto sit inside the frontal opening and provide a leak free seal to thevalve with no expiratory air required to seat the ball in the opening(“biased-closed position”). In the other mode with the valve oriented“up”, the ball has a tendency to sit away from the frontal opening,closer to the posterior opening of the chamber, providing a more openairflow passage (“biased-open position”) hence allowing the patient tobreathe easier. Additionally, the ball now requires a conscious effortin terms of exhalation force, to seat the ball in the frontal hole andseal off airflow. Because of this, exhaled air can either be allowed toexit through the valve rather than being redirected through thepatient's upper airway. Alternately, the patient can force the ball toseat when re-direction of airflow is desired for speech production.

In the “bias open” position, exhaled air flows freely through the valve,hence allowing the improved tracheotomy speaking valve to becoupled/effective with a new Heat Moisture Exchange (HME) filter thatfits over the improved speaking valve as a cap, enabling the patient tobreathe inhaled air that is at substantially the same temperature andcontaining the same quantities of moisture and dust as if it had reachedthe trachea after passing through the upper airway (nostrils, nose,pharynx and larynx).

It is an object of the present invention to provide a heat moistureexchange device which is usable with a tracheotomy tube combined with aspeaking valve and also with a tracheotomy tube or a speaking valve.

In accordance with the teachings of the present invention there isdisclosed a heat moisture exchange device comprising a housing adaptedto be received on an end of a tracheotomy tube, wherein exhaled andinhaled air may move into and out of the housing. The housing has adomed frontal wall and circumferential walls depending from the domedfrontal wall. A bottom circular panel is joined to the circumferentialwalls. A circular opening is formed in the bottom panel. A plurality oflegs are connected to the bottom panel extending upwardly within thehousing toward the domed frontal wall. The legs are substantiallyparallel to the circumferential walls. A plurality of spaced-apartopenings are formed in the circumferential walls. Means are disposedwithin the housing to produce turbulent air flow within the housing. Aheat and moisture exchange filter is mounted within the housing throughwhich the air flows wherein moisture and heat from the exhaled air istransferred to the filter and inhaled air is heated and moisturized bythe filter. Particulates in the air are collected by the filter.

The HME has a special design and shape that allows a more efficientexchange of heat and humidification and more efficient air filtration bymaking the air flow in a turbulent pattern inside the housing of theHME, rather than a linear pattern.

In addition, in accordance with the teachings of the present invention,there is disclosed a speaking valve for use with a tracheotomy device. Abody has a proximate end and a distal end, respectively. The distal endof the cylinder has an opening formed therein. The body has a ramp meansformed therein. A ball is disposed in the body between the ramp meansand the opening and trapped therein. The ramp means includes a pair ofsubstantially-parallel ramps spaced laterally apart a distance which isless than the diameter of the ball.

It also is the object of this invention to describe a method of usingthe HME with a dynamic ball speaking valve that can function either as“biased-closed” or “biased-open” depending on the orientation of thevalve oriented (up or down).

These and other objects of the present invention will become apparentfrom a reading of the following specification taken in conjunction withthe enclosed drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view showing a tracheotomy tube worn by apatient.

FIG. 2 is a perspective view of a tracheotomy tube with the valve of thepresent invention.

FIG. 3 is a cross-section taken along the lines 3-3 of FIG. 2 with theindexing means in a down position.

FIG. 4 is a cross-section view taken along the lines 4-4 of FIG. 3.

FIG. 5 is a partial cross-section view of the tracheotomy to be worn bythe patient with the indexing means of the present invention in the downposition and showing airflow when the patient stops inhaling.

FIG. 6 is a cross-section view corresponding to the view taken acrossthe lines 3-3 of FIG. 2.

FIG. 7 is a cross-section view across the lines 7-7 of FIG. 6.

FIG. 8 is a partial cross-section view of the tracheotomy tube worn bythe patient with the indexing means of the present invention in the downposition showing airflow when the patient inhales.

FIG. 9 is a cross-section view corresponding to the view taken acrossthe lines 3-3 of FIG. 2, however, with the indexing means in the upposition when the patient inhales.

FIG. 10 is a cross-section view across the lines 10-10 of FIG. 9.

FIG. 11 is a partial cross-section view of the tracheotomy tube worn bythe patient with the indexing means of the present invention in the upposition showing airflow when the patient inhales.

FIG. 12 is a cross-section view corresponding to the view taken acrossthe lines 3-3 of FIG. 2, however, showing the indexing means in the upposition when the patient exhales.

FIG. 13 is a partial cross-section view of the tracheotomy tube worn bythe patient with the indexing means of the present invention in the upposition showing airflow when the patient exhales.

FIG. 14 is a cross-section view corresponding to the view taken acrossthe lines 3-3 of FIG. 2, however, the indexing means is in the upposition when the patient exhales with increased force.

FIG. 15 is a partial cross-section view of the tracheotomy tube worn bythe patient with the indexing means of the present invention in the upposition showing airflow when the patient exhales with increased force.

FIG. 16 is a cross-section view showing tab on the ring received innotch in the body.

FIG. 17 is an exploded view of the valve of the present invention.

FIG. 18 is a perspective view showing a protrusion as the indexingmeans.

FIG. 19 is a perspective view showing a Heat Moisture Exchangeattachment to the valve.

FIG. 20 is a perspective view of a heat moisture exchange device of theprior art.

FIG. 21 is a perspective view of another heat moisture exchange deviceof the prior art.

FIG. 22 is a schematic drawing showing linear air flow through the heatmoisture exchange media.

FIG. 23 is a perspective view of a heat moisture exchange device of theprior art.

FIG. 24 is a bottom plan view of the present invention.

FIG. 25 is a side elevation view of the present invention.

FIG. 26 is a cross section view taken across the lines 26-26 of FIG. 24.

FIG. 27 is a top perspective view of the present invention.

FIG. 28 is a cross sectional view showing air movement into and out ofthe housing.

FIG. 29 is a graphical depiction of friction factor vs. critical Roswellmember.

FIG. 30 is a cross sectional view of the housing mounted on the speechvalve showing the dead space area.

FIG. 31 is a bottom perspective view showing vanes within the cap toproduce turbulent air movement.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1, a tracheotomy tube 10 is surgically implanted inthe throat of a patient for airway management. On the end of thetracheotomy tube extending outwardly from the patient's throat at anangle of approximately 20°, there is removably-mounted the speech valve12 of the present invention (FIG. 2).

The speech valve 12 has a body 14 with a first end 16 which communicateswith the outer end of the tracheotomy tube 10. The diameter of the firstend 16 of the body is larger than the diameter of the second end 18 ofthe body forming a chamber having an internal step 20 within the body 14(as shown in FIG. 3). The first end of the body is open. The second end18 of the body 14 has a frontal opening 26 formed therein which isoffset from the central axis 22 of the body. Within the body are aplurality of circumferentially spaced ramps 24. A portion of each rampslopes upwardly at an acute angle toward the first end of the body.Preferably, there are two parallel ramps 24, although more or fewerramps may be used. Within the body, between the frontal opening 26 andthe ramps 24, there is disposed a ball 28. The ball has a diameter whichis larger than the diameter of the frontal opening 26 in the second endof the body. The ramps are spaced apart a distance which is less thanthe diameter of the ball 28 to retain the ball within the body 14. Theramps form a channel or guide to keep the ball along a midline axis 22,making movement of the ball less turbulent and more efficient. The rampshave a defined slope to hold the ball fully forward toward the frontalopening 26 as will be described. The direction of movement of the ballis shown by the open arrow. Thus, in an “in rest” position when the body14 is in a desired approximately horizontal position, the ball 28 isautomatically seated against the frontal opening 26, thereby sealing thefrontal opening when the patient is neither inhaling nor exhaling (FIGS.3-5). The air passageway in the patient's upper airway is open for thepassage of air and air passes over the vocal cords 40 enabling thepatient to speak.

There is an indexing means 30 formed on the second end 18 of the bodywhich is used to determine the orientation of the body 14. The body maybe rotated through 180° by the patient (or the patient's caregiver) toprovide an “up” and a “down” position of the body. The outer surface ofthe body may have threads 32 or ribs formed thereon to provide a bettergrip to rotate the body.

In a preferred embodiment the indexing means 30 is a notch or non-roundportion of the second end of the body located near the frontal openingin the body. Alternately, as shown in FIG. 16, the indexing means may bea protrusion extending outwards from the second end of the body. Otherindexing means known to persons skilled in the art may be used toprovide an indexing means that may be sensed tactilely by the patient.

As shown in FIGS. 6-8, when the indexing means in the “down” position,and the patient inhales, the incoming air moves the ball up the ramps 24toward the tracheotomy tube 10 and air flows around the ball, betweenthe ramps and into the patient's lungs.

With the indexing means in the “up”/biased-open position (FIGS. 9-11),and the patient in the resting position, the ball rests posteriorly inthe chamber toward the tracheotomy tube, allowing free flow of air. Asthe patient inhales, incoming air flows over the ball, between theramps, and into the patient's lungs.

With the indexing means in the “up” position, when the patient exhales(FIGS. 12 and 13), the ball is displaced toward the frontal opening butthe ball does not rise upwardly to the eccentrically formed frontalopening which is near the upper portion of the body when in the “up”position. No seal occurs in the frontal opening and air moves out of thepatient's lungs, through the tracheotomy tube, and exits out of thevalve.

However, with the indexing means in the “up” position, if the patientincreases the exhalation force, the ball is forced upwardly in thechamber and the ball seats in the frontal hole wherein air does not flowthrough the valve but the air is forced through the upper airway of thepatient. In this scenario, the patient can speak since air is passingover the patient's vocal cords 40.

Thus, in a preferred embodiment, the present invention allows a methodof using the speaking valve in two different positions (“up” or “down”),and providing a positive ball positioning feature depending on how thehousing chamber is rotated, hence greatly improving performance. In the“down” mode the ball is automatically directed forward and held fullyseated towards the front opening of the valve body, when the patient isbreathing regularly at rest. This innovation allows the ball to sitinside the frontal opening and provide a leak free seal to the valvewith no expiratory air required to seat the ball in the opening(“biased-closed position”). In the “up” mode, the ball has a tendency tosit away from the frontal opening, closer to the posterior opening ofthe chamber, providing a more open airflow passage (“biased-openposition”) hence allowing the patient to breathe easier. Additionally,the ball now requires a conscious effort in terms of exhalation force,to seat the ball in the frontal opening and seal off airflow. Because ofthis, exhaled air can either be allowed to exit through the valve ratherthan being redirected through the patient's upper airway. Alternately,the patient can force the ball to seal when re-direction of airflow isdesired for speech production.

The ramps 24 are connected to a ring 34 which is disposed against theinternal step 20 such that the ramps 24 extend inwardly into the chamberin the body 14. The ring 34 is keyed and ultrasonically welded to thestep of the body to retain the ramps in place and in a properorientation (FIG. 16). The keying means 36 may be a tab formed on thering with a cooperating notch formed in the step, or the tab may beformed on the step and the notch may be formed on the ramp's ring. Otherkeying means known to persons skilled in the art may be used.

In an alternate mode, the valve including the body, the ramps and theball, is mounted in the cannula of the tracheotomy tube. Although thevalve cannot be rotated, the valve operates in a manner as describedabove.

Having the exhaled air from the patient make contact with heat moistureexchange (HME) media is essential to the function of an HME. Because HMEfilters function only when air from the patient is exhaled across themedia, and then returned to the patient, use of an HME is not possiblewith all other current unidirectional speaking valves which do not allowtwo-way airflow (air in and air out). Prior to the valve design of thepresent invention, patients had to choose either to wear a speakingvalve for communication and forgo the benefit of an HME filter, oralternatively to wear an HME filter and forgo the benefits of wearing aspeaking valve (FIGS. 20, 21 23). In the present invention a cap 38containing fibers for HME is removably attached to the second end of thebody. The novel ball valve's guiding design is unique in a sense thatwhen the indexing means is in the “up” position (biased-open), the ballrests posteriorly inside the chamber, greatly facilitating airflowduring inhalation (FIGS. 9, 10, 11). This position accommodates the useof an HME as follows. Upon exhalation, air is uniquely allowed to flowback out through the valve, and through the HME, making contact with thefilter media. In this way the patient receives the benefit of the HMEfiltered air upon inspiration. However, with the valve in this sameposition, the patient can also choose to have the ball seat and seal atwill, allowing redirection of the exhaled air over the vocal cords, inorder to produce speech. No repositioning of the valve itself isnecessary to achieve this. This is accomplished simply by providingincreased expiratory volume in order to drive the ball forward andvertically up the frontal wall, and into the frontal opening to seat theball and seal off airflow (FIG. 15).

This speaking valve uniquely allows the tracheotimized patient torealize the benefits of both automatic speech and humidificationconcurrently.

FIGS. 20, 21 and 23 show examples of HME's on the market, which aredesigned to be used directly over tracheotomy tubes (with or without thepatient being on a ventilator). Having exhaled air from the patient makecontact with the HME media is essential to the function of an HME,because HME filters function only when air from the patient is exhaledacross the media, and then returned to the patient.

Current HME's on the market provide humidification and heat exchange asthe inhaled/exhaled air flows through the HME device in a linear fashion(see FIG. 22).

The current designs resort to a large frontal area for sufficient mediavolume to achieve humidification, with the resulting bulkiness,increased weight and size, making them uncomfortable and unappealing topatients hence limiting their clinical acceptance (see FIG. 23).

In the present invention, a housing 42 is adapted to be received on anend of a tracheotomy tube 10 wherein exhaled and inhaled air may moveinto and out of the housing. The housing has a domed frontal wall 46. Abottom circular panel 58 is joined to the circumferential walls 48. Acircular opening 60 formed centrally in the bottom panel 58. A pluralityof legs 62 are connected to the bottom panel 58, the legs extendingupwardly within the circular opening 60 toward the domed frontal wall46. The individual legs 62 are separated from the adjoining leg 62 by anarrow slit wherein the legs have a degree of flexibility. The legs 62are substantially parallel to the circumferential walls 48.

A plurality of spaced-apart openings 50 are formed in thecircumferential walls 48. Dead space 52 is formed within the housing 42,preferably bounded by the domed frontal wall 46.

A filter media 54 is formed as a sheet which is disposed completelyaround the housing between the interior of the circumferential wall 48and the legs 62 extending upwardly from the bottom panel 58. In thismanner the filter media covers all of the spaced-apart openings 50 sothat air moving into or out of the housing must traverse the filtermedia. It has been found that porous reticulated ester-type polyurethanefoam having a pore size of 65 pores per inch is satisfactory in thepresent invention. This is not a limitation on the filter media andother types of foam with other pore sizes may be used. Pore sizes areavailable from 40 ppi to 90 ppi with 50 ppi to 70 ppi being most common.The filter media may not be a foam but could be a filter paper. Thefilter media is impregnated with a hygroscopic material. Calciumchloride has been found to be a satisfactory hygroscopic material.

The effectiveness of the present invention is enhanced by producingnonlinear turbulent air flow within the housing. A dimple 56 formedcentrally, interiorly of the domed frontal wall 46 is an effective meansto produce turbulence (FIGS. 26-28). The turbulence assures goodhumidification and heat transfer of the air as it passes through thefilter. Other means to produce turbulence in the air movement within thehousing such as vanes 64 within the housing may be used (FIG. 31).However, the turbulence must not be excessive so as to produceresistance to air flow.

The filter also removes particulates from the air. This is veryimportant for a patient having a tracheotomy tube because the normalfiltering by the nasal passages is not available.

The present invention is a new low-profile, high-performance heatmoisture exchange device 42, based on air recirculation (turbulent airflow rather than linear airflow). This new compact HME takes advantageof its smaller size, and uniquely discrete profile design to maintain avery low visual profile (FIGS. 25, 27). It sits like a cap over thetracheotomy cannula 10 or the speaking valve 12 (FIGS. 25, 27). The HMEhas a diameter of approximately 1 inch and a height of approximately ⅝inch. In addition, this HME incorporates unique design elements foroptimal and efficient air flow and while maintaining a high level ofhumidification and heat transfer.

Air flows from the trachea (through the tracheotomy tube and/or thespeaking valve) and gets redirected from the center of the HME when itencounters the dimpled/curved section in the center of the frontal wall46. The airflow is directed towards multiple smaller openings 56 thatare located on the side walls 48 and/or the bottom walls 52 of the HMEhousing 10 (FIGS. 25, 26, 27). This recirculation of air promotes flowinstability and transition to turbulence, which intensity will increasewith the speed of airflow. Turbulent flow, which may naturally occurwithin the lungs, is chaotic and involves multiple irregular eddiescurrents (circular currents) of air of many different length scales.When flow is turbulent, particles exhibit additional transverse motion,which results in increased rates of mass, momentum and heat exchange.

The enhancement of heat and momentum transfer is frequently expressed interms of turbulent transport rates, namely according to:

$q = {{- k_{turb}}\frac{\partial\overset{\_}{T}}{\partial y}}$$\tau = {\mu_{turb}\frac{\partial\overset{\_}{u}}{\partial y}}$where q is the heat flux, τ is the shear stress, T is the meantemperature field, ū is the mean velocity, μ_(turb) is the turbulentviscosity and k_(turb) is the turbulent thermal conductivity. Theenhanced transport arising in turbulent flow is directly linked to thefact that the turbulent viscosity and thermal conductivity aresubstantially larger than the molecular viscosity and thermalconductivity. Thus, with the same mean gradients, the turbulenttransport rates are substantially larger than the corresponding laminarrates.

As discussed below, it is advantageous to conceive HME filter so thattransitional and/or turbulent flow occurs during part or all thebreathing cycle. The onset of turbulence can be characterized in termsof the oscillating Reynolds number

$R_{os} = \frac{UD}{v}$where U is the amplitude of the cross-sectional mean velocity, D is thediameter (or alternatively the so-called hydraulic diameter), and ν thekinematic viscosity of the fluid. Specifically, turbulence occurs whenthe R_(os) exceeds a critical value, which may depend on the reducedfrequency:

$\omega^{\prime} = \frac{2\pi\; D^{2}}{4{vT}}$where T is the fundamental period of the oscillations, and D is thehydraulic radius. (M. O. Carpinlioglu, M. Y. Gundogu, “A critical reviewon pulsatile pipe flow studies directing towards future researchtopics,” Flow Measurement and Instrumentation 2001, 12:163-174, ElsevierPress. T. S. Zhao, P. Cheng, “Experimental studies on the onset ofturbulence and frictional losses in an oscillatory turbulent pipeflow,”, Int. J. Heat and Fluid Flow, 1996, 17:356-362, Elsevier Press).Correlations for the critical Reynolds number, R_(os.crit), are readilyavailable; for instance:R_(os,crit)=780√ω′, 2.3≤√ω′≤8.8R_(os,crit)=710√ω′ 4.0≤√ω′≤40.0R_(os,crit)=400√ω′ 42.0≤√ω′≤71.0

Thus, the above expressions may be used to ensure that the HME filterincludes one or more channels whose dimensions result in supercriticalReynolds number. In one embodiment of this invention, the HME filter isthus designed to operate in a regime where the flow has a supercriticalReynolds number.

In other embodiment of this invention, the critical Reynolds number fora specific design of the HME filter is determined experimentally. Forinstance, it is well known that when transition to turbulence occurs,the cycle averaged friction factor C _(f) changes from having anessentially inverse dependence on the Reynolds number, to beingessentially Reynolds-number independent. The cycled averaged frictionfactor may be readily obtained from the instantaneous pressure drop,which may be measured using mechanical or piezoelectric pressure gauges.

Thus, in one embodiment of this invention, a family of prototypes isevaluated. For each prototype the cycle-averaged friction factor ismeasured, and the measured values are plotted against R_(os) (FIG. 29).When a logarithmic scale is used, the cycle-averaged friction factorwould exhibit a branch with a −1 slope at low Reynolds number, and asecond branch that is essentially flat at high Reynolds number. Thecritical Reynolds number, R_(os,crit), may then simply be determined asthe intersection of these two branches.

Thus, in one embodiment of this invention, the HME filter is designed tooperate in a flow regime where the Reynolds number is above the criticalvalue determined experimentally above.

An effective approach to control the Reynolds number is to consider theeffect of the hydraulic diameter, D, on R_(os). Specifically, R_(os) maybe related to the flow rate amplitude, Q, the diameter, D, and thekinematic viscosity, ν, by:

$R_{os} = \frac{Q}{4\pi\;{Dv}}$

Thus, for fixed flow rate amplitude, Q, the Reynolds number increases asD decreases. In other words, the Reynolds number, R_(os) may beincreased by reducing the size of contractions or throats in the HMEfilter. It should be clear for someone skilled in the art how to extendthis approach to achieve similar effects, namely by altering sizes orshapes of HME filters disclosed herein. In testing where Q is a fixedflow amplitude of 0.51/s, D is 4.2 mm and ν is 16 E −06 m²/sec, thedevice operates at R_(os) greater than approximately 600. One or more ofthe flow cross sections has a hydraulic diameter that is less than 5 mm.

This unique dimpled design was evaluated using HME performance testsaccording to ISO 9360-2: 2009 standard with 3 h runtime and testcondition 8 (Vt=500 mL, rate=15/min). The test equipment used wascertified and maintained in accordance with industry standards accordingto ISO 13485.

The design was tested according to these conditions and the resultsnoted. The volume of media contained in this HME was measured. The samevolume of media was tested according to the ISO 9360-2:2009 standard,using the same calibrated and certified test equipment, but in a“straight through” configuration per FIG. 22. The same volume ofidentical foam material was used in the tests.

Percent HME water loss (turbulent flow design):

-   -   A.1 15 mm Half 16.6 mg/L moisture LOSS=27.4 mg/L moisture        RETURNED.    -   A.2 15 mm Half 17.0 mg/L moisture LOSS=27.0 mg/L moisture        RETURNED.

Comparison HME media (linear flow design)

-   -   Linear Sample #1 21.0 mg/L moisture LOSS=23.0 mg/L moisture        RETURNED.    -   Linear Sample #2 18.7 mg/L moisture LOSS=25.3 mg/L moisture        RETURNED.

Comparing the 23.0 mg/l return of the linear design to the 27.4 mg/lreturn of the dimple design, the dimpled housing design showed anincrease of 19% in efficiency for moisture output to the patient, ascompared to the straight through design using identical media volume andtest conditions. The only variable in the comparison tests were theshape of the housing. All other conditions were held identical.

This would indicate that the unique shape, with its increased contacttime, increased in friction and more complex air currents and eddiesresulted in an increase in moisture output. This translates to increasedeffectiveness and physiological benefit for the patient.

The domed frontal wall 46 provides additional dead space/volume 52within the small profile of this HME. The dead space affects the crosssection of the area through which air flows, and further slows downairflow, hence resulting in enhancement of humidification and heattransfer (FIG. 30).

Air flow is affected by different factors including: 1. thecross-sectional area of the airway (which determines resistance); 2.nature of airflow (turbulent vs. laminar); 3. Reynolds' number (whichdepends on the density of the media through which air flows); 4.presence of dead space, and 5. the breathing effort by the patient (seebelow).

In one embodiment of this invention, the HME filter comprisespassageways where the cross-sectional area changes rapidly. It is wellknown that when a stream is forced over such step or expansion, the flowseparates which results in the generation of a recirculating region inthe wake of the step or expansion region. Recirculating flow regionsserve as effective reservoirs of heat and humidity, which benefits theoperation of the device and ultimately the patient.

The heat and exchange moisture media preferably consists of reticulatedester-type polyurethane foam with a nominal porosity of 65 ppi (poresper inch). The material is die-cut into a hollow cylinder andsubsequently treated with an aqueous solution of pharmaceutical gradecalcium chloride. Other hygroscopic materials may be used. The foam isdisposed internally in the housing such that air entering or leaving thespaced-apart openings in the housing must pass through the foam.

Having exhaled air from the patient make contact with the HME media isessential to the function of an HME. Because HME filters function onlywhen air from the patient is exhaled across the media, and then returnedto the patient, use of an HME is not possible with any of the otherunidirectional speaking valves currently on the market, as they do notallow two-way air flow. Prior to this valve design, patients had tochoose either to wear a speaking valve for communication and forgo thebenefit of an HME filter, or alternatively to wear an HME filter andforgo the benefits of wearing a speaking valve. The novel ball valve'sguiding design is unique in a sense that when the housing is in the“notch up” position, the ball sits back toward the retention tabsgreatly facilitating air flow inhalation (ball is in “biased-open”position). This position accommodates the use of an HME as follows. Uponexhalation, air is allowed to flow back out through the valve, andthrough the HME when attached. In this way the patient receives thebenefit of the HME filtered air upon inspiration. However, with thevalve in this same position, the patient can also choose to have theball seat and seal, allowing redirection of the exhaled air over thevocal cords, in order to produce speech. This is accomplished simply byproviding increased expiratory volume in order to drive the ball forwardand vertically up the frontal wall, and into the frontal opening to seatand seal off air flow. When the patient decides to give preferentialpriority to speech, rather than humidification, all that needs to bedone is to rotate the valve 180 degrees and the ball moves forwardtowards the frontal opening (ball is in “biased-closed” position). Thisallows the patient to realize the benefits of either speech orhumidification (FIG. 8).

What is claimed is:
 1. A heat moisture exchange device comprising ahousing adapted to be received on an end of a tracheotomy tube, whereinexhaled and inhaled air may move into and out of the housing, thehousing having a domed frontal wall and circumferential walls dependingfrom the domed frontal wall, a bottom circular panel joined to thecircumferential walls, a circular opening formed in the bottom panel,the domed frontal wall having a dimple extending toward the circularopening, a plurality of spaced-apart legs connected to the bottom paneland extending upwardly within the housing toward the domed frontal wall,the legs being substantially parallel to the circumferential walls, aplurality of spaced-apart openings formed in the circumferential walls,and a heat and moisture exchange filter mounted within the housingthrough which air flows, wherein moisture and heat from the exhaled airis transferred to the filter and inhaled air is heated and moisturizedby the filter and wherein particulates in the inhaled air are collectedby the filter.
 2. The heat and moisture exchange device of claim 1,wherein a speaking valve is mounted on the end of the tracheotomy tubeand the heat moisture exchange device is mounted on the speaking valvewherein a patient fitted with the tracheotomy tube, the speaking valveand the heat and moisture exchange device may breathe and speak.
 3. Theheat moisture exchange device of claim 2, wherein the speaking valvecomprises: a plurality of ramps extending upward at an acute angletowards a first end of the speaking valve; an opening at a second end ofthe speaking valve, wherein the opening is offset from a central axisextending from the first end to the second end of the valve; and a balldisposed between the opening and the plurality of ramps, wherein adiameter of the ball is greater than a diameter of the opening.
 4. Theheat moisture exchange filter of claim 1, wherein the filter is a filtermaterial impregnated with a hygroscopic material.
 5. The heat moistureexchange device of claim 1, wherein the filter material is a porous foamhaving multiple pores, each pore having a nominal pore size ofapproximately 65 ppi.
 6. The heat moisture exchange device of claim 5,wherein the porous foam comprises ester-type polyurethane.
 7. The heatmoisture exchange device of claim 1, wherein athe dimple is formedcentrally on the domed frontal wall, the dimple being arranged toproduce turbulence in movement of air moving within the housing.
 8. Amethod of using the heat moisture exchange device of claim 1 comprising:with a tracheotomy tube whereinmounting the heat moisture exchangedevice is mounted on the end of the tracheotomy tube andcontrolscontrolling the temperature and moisture content of the airbeing inhaled and exhaled through the mounted heat moisture exchangedevice and the tracheotomy tube.
 9. A heat moisture exchange devicecomprising a housing adapted to be received on a speaking valve which ismounted on an end of a tracheotomy tube in a patient fitted with thetracheotomy tube, wherein air may move into and out of the housing, thehousing having a domed frontal wall and circumferential walls dependingfrom the domed frontal wall, a bottom circular panel joined to thecircumferential walls, a circular opening formed in the bottom panel, aplurality of spaced-apart legs connected to the bottom panel andextending upwardly within the housing toward the domed frontal wall, thelegs being substantially parallel to the circumferential walls, aplurality of spaced-apart openings formed in the circumferential walls,means for modifying air flow disposed within the housing to producenonlinear turbulent air flow within the housing, a heat and moistureexchange filter mounted within the housing between the legs and theopenings in the circumferentially circumferential walls through whichair flows, wherein moisture and heat from the exhaled air is transferredto the filter and inhaled air is heated and moisturized by the filterand wherein particulates in the inhaled air are collected by the filter,and wherein the means disposed within the housing to produce nonlinearturbulent airflow within the housing for modifying air flow is a dimpleformed on the domed frontal wall extending towards the circular opening.10. The heat moisture exchange filter of claim 9, wherein the filter isa filter material impregnated with a hygroscopic material.
 11. The heatmoisture exchange device of claim 9, wherein the means to producenonlinear turbulent air flow within the housing is the dimple is formedcentrally on the domed frontal wall.
 12. The heat moisture exchangedevice of claim 9, wherein the turbulence is expressed as$R_{os} = \frac{Q}{4\;\pi\;{Dv}}$ where Q is a fixed flow amplitude, Dis a generic diameter of the heat moisture exchange device and ν is thekinematic viscosity of air and the device operates at R_(os) greaterthan approximately
 600. 13. The heat moisture exchange device of claim12, wherein one or more flow cross sections have a hydraulic diameterthat is less than 5 mm.
 14. A method of using the heat moisture exchangedevice of claim 9 comprising withmounting the heat moisture exchangedevice on the speaking valve, and tracheotomy tube wherein the heatmoisture exchange device controlscontrolling the temperature andmoisture content of the air being inhaled and exhaled through themounted heat moisture exchange device and the tracheotomy tube andwhereinas the patient may breathe and speakbreathes and speaks.
 15. Aheat moisture exchange device comprising: a housing configured to bereceived on an end of a tracheotomy tube, the housing having a domedfrontal wall, wherein the domed frontal wall has a dimple; sidewallsextending downward from the domed frontal wall, wherein the sidewallsare perforated; a panel connected to a distal portion of the sidewalls;a plurality of legs extending from the panel toward the domed frontalwall; and a filter within the sidewalls of the housing; wherein thedimple is extending extends in the same direction as the sidewalls. 16.The heat moisture exchange device of claim 15, wherein the filter is aporous foam having a plurality of pores, wherein each of the pluralityof pores range from 40 ppi to 90 ppi.
 17. The heat moisture exchangedevice of claim 16, wherein the porous foam comprises ester-typepolyurethane.
 18. The heat moisture exchange device of claim 15, whereinthe filter comprises a hygroscopic material.
 19. The heat moistureexchange device of claim 15, wherein the filter comprises calciumchloride.
 20. The heat moisture exchange device of claim 15, wherein thehousing has a diameter of 1 inch.
 21. The heat moisture exchange deviceof claim 2, wherein the speaking valve further comprises: a bodyconfigured for being attached to and rotatable relative to thetracheotomy tube between a biased-closed position and a biased-openposition, the biased-open position being 180° offset from thebiased-closed position, the body having a first end configured forcommunicating with the tracheotomy tube, a second end distal from thetracheotomy tube configured for communicating with the heat and moistureexchange device, a cylindrical chamber extending from the second end,and an opening formed in the second end offset from a central axis ofthe chamber; a ball disposed within the chamber, the ball having adiameter greater than the opening; and a plurality of guides disposedwithin the cylindrical chamber and arranged for guiding movement of theball within the chamber between a first position and a second position;wherein, when the body is rotated to the biased-closed position, theguides have a first region configured and positioned to urge the balltoward and substantially close the opening, and wherein, in response toa sufficient inhalation flow, the guides have a second region configuredand positioned to urge the ball toward a substantially central positionwithin the chamber and thereby define a generally annular flow passage.22. The heat moisture exchange device of claim 21, wherein, when thebody is rotated to the biased-open position, the guides guide the ballto an offset position within the chamber whereby the opening remainssubstantially unobstructed, and wherein, in response to a sufficientinhalation flow, the guides urge the ball toward a substantiallyrearward position within the chamber.
 23. A speaking valve comprising: abody having a first end configured for being removably attached to atracheotomy tube; a second end configured for receiving a removablyattached heat and moisture exchange device, the body further beingrotatable relative to the tracheotomy tube between a biased-closedposition and a biased-open position, the biased-open position being 180°offset from the biased-closed position, the body having a cylindricalchamber extending from the second end, and an opening formed in thesecond end offset from a central axis of the chamber; a ball disposedwithin the chamber; and a plurality of guides disposed within thecylindrical chamber and arranged for guiding movement of the ball withinthe chamber between a first position and a second position; wherein,when the body is rotated to the biased-closed position, the guides havea first region configured and positioned to urge the ball toward andsubstantially close the opening, and wherein, in response to asufficient inhalation flow, the guides have a second region configuredand positioned to urge the ball toward a substantially central positionwithin the chamber and thereby define a generally annular flow passage.